Replacement Heart-valve

Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

Hancock II T510 Bioprosthesis, Mitral, REF T505U227 -

Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012.

Medtronic has decided to discontinue production and distribution of this low-volume product.

Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only;

Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.

Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID , T505C2301, T505C2301, T505C2501, T505C2101,

Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.